Clinical trial

Study on the Application of Hyperspectral Imaging Technique in the Treatment of TAC

Name
TAC-IMN-HSI
Description
We propose hyperspectral imaging analysis as a method to identify the efficacy of hormone-tacrolimus therapy for PMN, and to classify sensitive and insensitive patients treated with hormone-tacrolimus regimen. A variety of machine learning models were used to prove that hyperspectral imaging technology could assist patients in selecting the optimal treatment plan, and further explore the predictive indicators of PMN treatment effect.
Trial arms
Trial start
2023-04-25
Estimated PCD
2023-07-20
Trial end
2023-12-30
Status
Not yet recruiting
Treatment
Tacrolimus for the treatment of IMN
Remission after tacrolimus treatment of IMN
Arms:
TAC group in remission, TAC group without remission
Size
40
Primary endpoint
Microhyperspectral image of a transrenal specimen
2023.4-2023.12
Eligibility criteria
Inclusion Criteria: * Over 18 years old; * Patients with idiopathic membranous nephropathy confirmed by renal biopsy; * Had not received hormone and/or immunosuppressive therapy before renal biopsy; * Complete clinical data, all signed the "Admission Certificate of Qianfoshan Hospital of Shandong Province", and agreed to use relevant medical information, biological specimen examination and examination results for scientific research. Exclusion Criteria: * There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or poisons, etc; * Severe infection: fever, cough and expectoration, sore throat, abdominal pain, diarrhea, carbuncle and furuncle and other clinical manifestations of skin and soft tissue infection, blood routine white blood cell count beyond the normal range (10×109/L); * Severe cardiovascular disease: including chronic heart failure grade 3 or above and various arrhythmias; * Infectious diseases: active hepatitis, AIDS, syphilis, etc. ; * Tumor evidence: it has been found that there is a certain tumor or clinical manifestations, tumor markers, etc.,suggesting the possibility of tumor; * Patients with follow-up time less than 6 months, incomplete data or missed diagnosis.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'OTHER'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Renal aspiration biopsy pathology'}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-04-04

1 organization

1 product

3 indications

Product
Tacrolimus
Indication
Tacrolimus